Country: Malta
Language: English
Source: Medicines Authority
ROSUVASTATIN
1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Germany
C10AA07
ROSUVASTATIN 5 mg
FILM-COATED TABLET
ROSUVASTATIN 5 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2016-01-11
Page 1 of 10 PACKAGE LEAFLET: INFORMATION FOR THE USER ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS ROSUVASTATIN – 1 A PHARMA 40 MG FILM-COATED TABLETS ROSUVASTATIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Rosuvastatin – 1 A Pharma is and what it is used for 2. What you need to know before you take Rosuvastatin – 1 A Pharma 3. How to take Rosuvastatin – 1 A Pharma 4. Possible side effects 5. How to store Rosuvastatin – 1 A Pharma 6. Contents of the pack and other information 1. WHAT ROSUVASTATIN – 1 A PHARMA IS AND WHAT IT IS USED FOR Rosuvastatin – 1 A Pharma belongs to a group of medicines called statins. You have been prescribed Rosuvastatin – 1 A Pharma because: • You have a high cholesterol level. This means you are at risk from a heart attack or stroke. Rosuvastatin – 1 A Pharma is used in adults, adolescents and children 6 years or older to treat high cholesterol. You have been advised to take a statin, because changing your diet and taking more exercise were not enough to correct your cholesterol levels. You should continue with your cholesterol- lowering diet and exercise while you are taking Rosuvastatin – 1 A Pharma. Or • You have other factors that increase your risk of having a heart attack, stroke or related health problems. Page 2 of 10 Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atheros Read the complete document
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rosuvastatin – 1 A Pharma 5 mg film-coated tablets Rosuvastatin – 1 A Pharma 10 mg film-coated tablets Rosuvastatin – 1 A Pharma 20 mg film-coated tablets Rosuvastatin – 1 A Pharma 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: 26 mg lactose anhydrous ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: 53 mg lactose anhydrous ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS Each film-coated tablet contains 20 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: 106 mg lactose anhydrous ROSUVASTATIN – 1 A PHARMA 40 MG FILM-COATED TABLETS Each film-coated tablet contains 40 mg rosuvastatin (as rosuvastatin calcium). Excipients with known effect: 212 mg lactose anhydrous For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet ROSUVASTATIN – 1 A PHARMA 5 MG FILM-COATED TABLETS Brown, round, film-coated tablets with a diameter of 5 mm. ROSUVASTATIN – 1 A PHARMA 10 MG FILM-COATED TABLETS Brown, round, film-coated tablets, with a diameter of 6 mm, with “RSV 10”debossed on one side. ROSUVASTATIN – 1 A PHARMA 20 MG FILM-COATED TABLETS Brown, round, film-coated tablets, with a diameter of 8 mm, with “RSV 20”debossed on one side. ROSUVASTATIN – 1 A PHARMA 40 MG FILM-COATED TABLETS Brown, round, film-coated tablets, with a diameter of 10 mm, with “RSV 40”debossed on one side. Page 2 of 22 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TREATMENT OF HYPERCHOLESTEROLAEMIA Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjun Read the complete document